A variety of circumstances make it necessary or desirable to control the flow of bodily fluids from the urethral opening of the male penis. For instance, if contraception is not desired it is imperative that the male spermatozoa be prevented from entering the female vaginal canal. Numerous contraceptive devices are known in the art. The most common of these devices, the condom, is designed to sheath the penis in an impermeable protective covering which acts as a receptacle for ejaculant fluid to prevent unwanted pregnancies, and as a barrier, to prevent ingress or egress of undesirable microbes, such as gonorrhea, herpes, and the AIDS virus. Unfortunately, the use of a condom results in a loss of both spontaneity and sensitivity during intercourse. Additionally, the condom may leak or accidentally fall off, thereby causing infection or unwanted pregnancy.
Additionally, due to the side effects of disease, such as diabetes, or incidental to a surgical procedure, such as removal of the prostate, an adult male may become incontinent. Control of this condition is commonly achieved by wearing absorbent undergarments or, in extreme cases, by use of a urethral catheter and external urine reservoir.
Several devices are known which are designed to occlude either the urethra or the vas deferens.
For example, U.S. Pat. No. 5,474,089 to Waynant teaches a method of reversible sterilization which is accomplished by first inserting a blocking member into a duct in a subject's reproductive system, then altering the dimensions of the blocking member so as to engage and seal the blocking member in the duct and lastly, applying laser irradiation to ablate a portion of the blocking member thereby unblocking the duct. This device requires medical personnel for both the insertion and ablation of the device.
U.S. Pat. No. 4,139,007 to Diamond teaches a method of male contraception that utilizes external pressure applied to the underside of the penis at its base to close the urethral canal, thus preventing the escape of semen. Diamond utilizes a strap and pressure pad combination which must be accurately placed over the urethral canal. Improper placement of the device or accidental displacement thereof will allow semen to flow through the urethra thereby rendering the device inoperative.
U.S. Pat. No. 4,013,063 to Bucalo describes an implant for insertion in the vas deferens which is actuated to a closed position via the appropriate placement of external magnets. The use of this device requires surgical implantation. Furthermore, if the magnets accidentally become dislodged the device returns to the fully open configuration, thereby allowing the flow of spermatozoa through the urethral canal.
U.S. Pat. No. 5,701,914 to Loeffler is directed to a male contraceptive device which is inserted by the user into the urethral canal. Loeffler's device is formed as an expandable body unit having an elastic member covering a plurality of body segments. Upon insertion, the user must depress a small actuator handle which expand the device to block fluids from passing through the urethra. Subsequently, the handle must be further depressed to contract the device and allow for its withdrawal. The device is elliptically shaped and only expands 10% from its original shape. Thus, proper fitting to every male's anatomy is tenuous. Furthermore it requires that inward pressure be exerted in order to expand the device, which can cause the device to become too deeply embedded prior to actuation. Lastly, manipulation of the device requires a great deal of manual dexterity in order that it be utilized effectively.
Thus, what is lacking in the art is a device which can reliably and reversibly occlude the urethral canal. The device must be easily and readily insertable by the user and must be designed for reliable retention. Furthermore, the device should be suitable for retention of all bodily fluids when sealingly engaging the urethral opening.